asthma
Conditions
Interventions
investigational material(s)
Generic name etc : PTR-36
INN of investigational material :
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration for Investi
Sponsors
TEIJIN PHARMA LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Asthma patients receiving a moderate-dose ICS or a moderate-dose ICS/long-acting beta2-agonist(LABA)combination therapy for more than 4 weeks - FEV1 >=60% and =<90% of the predicted normal value at randomization
Exclusion criteria
Exclusion criteria: - BMI >= 30 - smoking history > 10 pack year - diagnosed with COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in mPEF from time of randomization to final evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in pre-bronchodilator FEV1, ACQ7, and FeNO | — |
Outcome results
None listed